Culturally Tailored Behavioral Diabetes Care Intervention for Korean Americans
Diabetes Care for Korean Americans
調査の概要
詳細な説明
Korean American immigrants (KAI), one of the most underserved and understudied minority populations in the U.S., suffer from diabetes, which goes under-diagnosed, inadequately treated and has a potential to result in costly and tragic consequences. Language barriers, the lack of self-confidence, and diminished social support that accompany the acculturation process prevent KAI from improving their health-seeking behaviors. Our previous research has indicated that overwhelming numbers of KAI suffer not only from uncontrolled hyperglycemia but also from a loss of self-confidence and social isolation because of language and cultural barriers. They are in urgent need of an intervention to assist them in their efforts to achieve better glycemic control and restore their self-confidence in diabetes and health management so that they are able to adjust successfully in this new environment. Therefore, The purpose of this study is to assess the feasibility and efficacy of a culturally-tailored, comprehensive behavioral intervention program specially designed for linguistically challenged KAIs with type 2 DM.
This pilot project will test the hypothesis: Compared to KAI in the control group, KAI with type 2 DM who receive a comprehensive DM management intervention through structured psycho-behavioral education, home glucose monitoring with a telephone transmission system, and interaction with a bilingual nurse case manager will show: (1) a greater level of glucose control; and (2) a greater level of self-help skills including knowledge related to glucose control, problem-solving skills, heightened confidence and mood/affect, adherence to treatment recommendations, and quality of life. An additional outcome will be to measure and obtain an ideal BP as the proposed intervention focuses on management of multiple risk factors with which many KA DM patients often struggle.
研究の種類
入学 (予想される)
段階
- フェーズ 1
連絡先と場所
研究場所
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Maryland
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Ellicott City、Maryland、アメリカ、20143
- Korean Resource Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Self-identified as a first generation Korean American
- Age 30 years or older
- Resides in Washington-Baltimore area
- Expresses willingness to participate in all aspects of the study over its full course
- Written consent to participate in the screening/eligibility visit
- Self-identified with DM and HbA1c >= 8% within 6 months of screening
- Written consent to participate in the clinical trial: agreeing to participate in study data collection procedures, receiving DM self -help education, using HGMT, and permitting contact with their own medical care provider.
Exclusion Criteria:
- Unable to give informed consent
- Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases)
- Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:1
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Intervention group participants receive a 6-week in-class education offered by trained nurses, followed by home glucose monitoring with monthly nurse telephone counseling.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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HbA1c
時間枠:30 Weeks
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The primary outcome varialbe is hemoglobin A1c level of the study participants to assess the status of blood gluocse management and control during previous 2-3 months.
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30 Weeks
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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BP control
時間枠:30 weeks
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30 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Miyong T Kim, PhD、Johns Hopkins University School of Nursing
出版物と役立つリンク
一般刊行物
- Song HJ, Han HR, Lee JE, Kim J, Kim KB, Nguyen T, Kim MT. Translating current dietary guidelines into a culturally tailored nutrition education program for Korean American immigrants with type 2 diabetes. Diabetes Educ. 2010 Sep-Oct;36(5):752-61. doi: 10.1177/0145721710376328. Epub 2010 Jul 22.
- Kim MT, Han HR, Song HJ, Lee JE, Kim J, Ryu JP, Kim KB. A community-based, culturally tailored behavioral intervention for Korean Americans with type 2 diabetes. Diabetes Educ. 2009 Nov-Dec;35(6):986-94. doi: 10.1177/0145721709345774.
- Nam S, Han HR, Song HJ, Song Y, Kim KB, Kim MT. Utility of a point-of-care device in recruiting ethnic minorities for diabetes research with community partners. J Health Care Poor Underserved. 2011 Nov;22(4):1253-63. doi: 10.1353/hpu.2011.0117.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。